AI Article Synopsis
Article Abstract
Objective: This two-stage Phase II study assessed the activity of single agent alisertib in patients with recurrent/persistent uterine leiomyosarcoma (uLMS).
Methods: Eligibility criteria included histologically-confirmed, recurrent or persistent uLMS, age≥18, 1-2 prior cytotoxic regimens, and RECIST version 1.1 measurable disease. The primary objective of the study was to evaluate the efficacy of alisertib through the frequency of patients with objective tumor responses and the frequency who survived event-free for at least 6months (EFS6). The endpoints for EFS were RECIST progression, death, or beginning a subsequent therapy. The null hypothesis jointly specified the probability of a patient experiencing a tumor response to less than or equal to 5% and the probability of a patient surviving event-free for at least 6months to less than or equal to 20%. A two-stage design was used with a target accrual of 23 patients for stage 1 and 47 pts. cumulative for stage 2. Confidence intervals do not correct for multiplicity.
Results: Twenty-three patients were enrolled with two patients excluded on central histology review, yielding 21 eligible patients. Median age was 61years. Prior treatment was either 1 cytotoxic regimen (71.4%) or 2 (28.6%). The most common treatment related AEs (grade 3 or worse) were anemia Hensley et al. (2008a) , leukopenia Hensley et al. (2008b) , neutropenia Maki et al. (2007) , thrombocytopenia Huang et al. (2012) , mucositis Hensley et al. (2008a) , diarrhea Huang et al. (2012) , and palmer-planter syndrome Zivanovic et al. (2012) . There were no objective responses (0%; 90% CI: 0-10.4%). Best response was stable disease (38.1%); 12 patients had progressive disease (57.1%). EFS6 was 0% (90% CI: 0-10.4%). Median PFS and OS were 1.7 (90% CI: 1.4-3.2) and 14.5months (90% CI: 7.6 - NA), respectively.
Conclusion: Alisertib did not demonstrate clinically meaningful single agent activity in previously treated uLMS.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5260802 | PMC |
| http://dx.doi.org/10.1016/j.ygyno.2016.10.036 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Barriers and Facilitators to the Participation of Pregnant Women in Clinical Research: A Mixed-Methods Systematic Review.
J Evid Based Med
December 2024
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Objectives: Pregnant women had a large demand for diagnosis and treatment, but the clinical research was not sufficient, and there were many barriers for pregnant women to participate in clinical research. This study aimed to systematically identify these barriers and facilitators, map them with Theoretical Domains Framework (TDF) and Behavior Change Techniques (BCTs) to inform the development of interventions promoting pregnant women's involvement in clinical research.
Methods: This was a mixed-methods systematic review.
Online native hydrophobic interaction chromatography-mass spectrometry of antibody-drug conjugates.
MAbs
December 2025
Synthetic Molecule Analytical Chemistry, Genentech Inc., South San Francisco, CA, USA.
Hydrophobic interaction chromatography (HIC) is commonly used to determine the drug-to-antibody ratio (DAR) and drug load distribution of antibody-drug conjugates (ADCs). However, identifying various DAR species separated by HIC is challenging due to the traditional use of mobile phases that are incompatible with mass spectrometry (MS). Existing approaches used to couple HIC with MS often encounter issues, such as complex instrumentation, compromised separation efficiency, and reduced MS sensitivity.
View Article and Find Full Text PDFRBIS regulates ribosome biogenesis to affect progression in lung adenocarcinoma.
J Transl Med
December 2024
Cancer Institute, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Background: Increased ribosome biogenesis is required for tumor growth. In this study, we investigated the function and underlying molecular mechanism of ribosome biogenesis factor (RBIS) in the progression of non-small cell lung cancer (NSCLC).
Methods: In our study, we conducted a comprehensive analysis to identify key genes implicated in ribosome biogenesis by leveraging a Gene Set Enrichment Analysis (GSEA) dataset.
Life cycle and morphogenetic differentiation in heteromorphic cell types of a cosmopolitan marine microalga.
New Phytol
December 2024
Department of Ecology, Evolution and Behaviour, The Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem, Jerusalem, 9190401, Israel.
Gephyrocapsa huxleyi is a prevalent, bloom-forming phytoplankton species in the oceans. It exhibits a complex haplodiplontic life cycle, featuring a diploid-calcified phase, a haploid phase and a third 'decoupled' phase produced during viral infection. Decoupled cells display a haploid-like phenotype, but are diploid.
View Article and Find Full Text PDFA Longitudinal Study of Vocal Symptomatology in Teachers During Distance, Hybrid, and In-Person Teaching.
J Voice
December 2024
Professor in the Speech, Language and Hearing Sciences Department of the Federal University of Sergipe - Lagarto Campus, Lagarto, Brazil. Electronic address:
Objective: To compare the vocal symptomatology of professors from a federal university who engaged in distance, hybrid, and face-to-face teaching during and after the Coronavirus Disease 2019 (COVID-19) pandemic period.
Method: The study included 40 university professors, 20 men and 20 women, whose symptomatology was monitored at three time points: during the distance teaching period due to social isolation caused by COVID-19, in hybrid teaching (partial return), and upon returning to face-to-face teaching, which required the use of face masks and posed contamination risks.
Results: The hybrid phase presented the highest absence of vocal complaints/discomfort, and most participants did not need to be reassigned due to vocal problems.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!